Rigel Pharmaceuticals, Inc. operates as a clinical stage biotechnology company. It discovers and develops novel, targeted drugs in the therapeutic areas of immunology, oncology and immune oncology. The firm focuses on intracellular signalling pathways and related targets that are critical to disease mechanisms. The company's products include Tavalisse, Fostamatinib and R835. Rigel Pharmaceuticals was founded by Donald G. Payan, James M. Gower, Thomas A. Raffin, Garry P. Nolan and Ronald B. Garren on June 14, 1996 and is headquartered in South San Francisco, CA.
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- Rigel Pharmaceuticals named Alison L. Hannah, M.D., as Executive Vice President and Chief Medical Officer, effective July 1, 2026, succeeding Lisa Rojkjaer, M.D. - Dr. Hannah brings decades of oncology drug development experience, including prior roles at CytomX Therapeutics and SUGEN, and has served on Rigel's Board of Directors since May 2021. - Her appointment comes as Rigel advances its lead pipeline asset R289, a dual IRAK1/4 inhibitor, through a Phase 1b study in relapsed or refractory lower-risk myelodysplastic syndrome. - The company expects to complete enrollment and select a recommended Phase 2 dose for R289 in the second half of 2026, with preliminary data anticipated by year-end.
- Rigel Pharmaceuticals published final Phase 1/2 ARROW study results in the Journal of Clinical Oncology, showing pralsetinib achieved a 70% overall response rate in patients with RET fusion-positive non-small cell lung cancer. - The study demonstrated median overall survival of 44.3 months in the overall population, with treatment-naïve patients achieving 50.1 months and prior-platinum patients reaching 39.7 months. - Pralsetinib showed intracranial activity with a 53% response rate in patients with measurable CNS metastases, supporting its potential value in advanced disease management. - The final data includes an additional 42 months of follow-up, reinforcing the drug's manageable safety profile with no new safety signals observed.
- Rigel Pharmaceuticals reported updated Phase 1b data for R289, an oral IRAK1/4 dual inhibitor, showing 33% of transfusion-dependent lower-risk MDS patients achieved red blood cell transfusion independence at doses ≥500 mg daily. - The study enrolled 33 heavily pre-treated patients with median age 75 and median 3 prior therapies, demonstrating R289's tolerability with manageable side effects including diarrhea, constipation, and fatigue. - Peak hemoglobin increases of 2.9 to 6.1 g/dL occurred in patients achieving transfusion independence, with median duration of 22.9 weeks and some patients maintaining independence for over 24 weeks. - The company plans to complete dose expansion with up to 40 patients and select the recommended Phase 2 dose in the second half of 2026.
- Rigel Pharmaceuticals has enrolled the first patient in the dose expansion phase of its Phase 1b study evaluating R289, a dual IRAK1/4 inhibitor, for transfusion-dependent relapsed or refractory lower-risk myelodysplastic syndrome. - The dose expansion phase will randomize up to 40 patients to receive 500 mg R289 either once or twice daily to determine the recommended Phase 2 dose for future clinical development. - R289 has received FDA Orphan Drug designation for myelodysplastic syndromes and Fast Track designation for previously-treated transfusion-dependent lower-risk MDS, addressing a persistent unmet medical need. - The company completed dose escalation enrollment in July 2025 and expects to share updated study data later this year, with an additional exploratory cohort planned once the recommended Phase 2 dose is established.
- Rigel Pharmaceuticals' lead product Tavalisse generated $68.5 million in sales during the first half of 2025, representing a 44% year-over-year increase. - The company's second FDA-approved drug Rezlidhia showed strong momentum with 31% year-over-year growth to $13.1 million in sales. - Rigel raised its 2025 revenue guidance to $270-$280 million from the previous expectation of $200-$210 million due to strong commercial performance. - The company is advancing R289, a dual IRAK1/IRAK4 inhibitor, in Phase Ib trials for myelodysplastic syndrome with dose expansion planned for the second half of 2025.
- Over 10 companies are developing 12+ RIPK1 inhibitor therapies targeting inflammatory and neurodegenerative diseases, with key players including Sanofi, Rigel Pharmaceuticals, and GenFleet Therapeutics advancing promising candidates. - Sanofi discontinued its Phase 2 trial of oditrasertib in multiple sclerosis after failing to meet primary endpoints, highlighting the challenges in targeting neurodegeneration with RIPK1 inhibition. - Leading pipeline candidates include SAR443122 for cutaneous lupus and ulcerative colitis, GFH312 as China's first clinical-stage RIPK1 inhibitor, and R552 developed through Rigel's collaboration with Eli Lilly. - RIPK1 inhibitors represent a novel therapeutic approach by blocking inflammation and cell death pathways, offering potential treatments for autoimmune disorders, neurodegenerative conditions, and inflammatory diseases.
- Final data from the Phase 1/2 ARROW study demonstrates GAVRETO's durable efficacy in RET fusion-positive NSCLC, with a 70.3% overall response rate and median overall survival of 44.3 months. - GAVRETO shows promising anti-tumor activity in various RET fusion-positive solid tumors beyond lung cancer, including a 100% response rate in pancreatic cancer patients. - REZLIDHIA data supports its potential clinical benefit when used in earlier treatment lines for relapsed/refractory AML patients and as maintenance therapy, with particularly strong outcomes in patients with fewer prior therapies.
- DelveInsight's 2025 assessment reveals a robust sickle cell disease pipeline with 55+ companies developing 60+ therapeutic candidates across various clinical development stages. - Recent clinical milestones include Rigel Pharmaceuticals enrolling the first patient in a Phase I trial of fostamatinib and Beam Therapeutics presenting updated BEACON trial data for BEAM-101. - The pipeline encompasses diverse therapeutic approaches including gene therapies, small molecules, and monoclonal antibodies, with treatments administered through multiple routes from oral to intravenous. - Key marketed therapies include Vertex Pharmaceuticals' CASGEVY, a CRISPR/Cas9 gene-edited cell therapy, and Emmaus Medical's ENDARI, an oral L-glutamine treatment for reducing acute complications.
• DelveInsight's latest report reveals a robust pipeline with 110+ companies developing 120+ therapies for acute myeloid leukemia (AML), showing significant investment in this aggressive blood cancer. • Several promising candidates are advancing through clinical trials, including GlycoMimetics' uproleselan in Phase III, BioSight's aspacytarabine (BST-236) in Phase II, and novel approaches like Senti Biosciences' logic-gated CAR-NK cell therapy. • Recent developments include Moleculin Biotech's Phase III MIRACLE trial for annamycin, Qurient's adrixetinib IND approval, and Rigel Pharmaceuticals' trial of REZLIDHIA in combination therapy for IDH1-mutated AML.
- Rigel Pharmaceuticals achieved significant revenue growth in 2024, with TAVALISSE sales increasing 12% to $104.8 million and REZLIDHIA sales growing 118% to $23.0 million. - The company secured key regulatory approvals for TAVALISSE in South Korea and Mexico, while establishing a new partnership with Dr. Reddy's Laboratories for REZLIDHIA commercialization across multiple territories. - Rigel's R289 program for lower-risk MDS received FDA Fast Track designation, with promising Phase 1b data presented at ASH 2024 showing good tolerability and preliminary efficacy.
